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adverse events

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EMA says Bayer’s Diane 35 should remain on European market

Agency investigation concludes acne treatment's benefits outweigh its risks

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Arena pulls obesity drug Belviq application in EU

EMA asks for more data

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GSK submits COPD drug in US and EU

Umeclidinium bromide intended as monotherapy for lung condition

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Court blocks EMA release of pharma company data

AbbVie and InterMune successfully challenge request for trial data for Humira and Esbriet

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Two new cancer drugs recommended in Europe

CHMP backing for Roche's Erivedge and Astellas' Xtandi

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EMA refuses to back Pfizer’s Xeljanz in rheumatoid arthritis

Surprise after approvals in US and Japan

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European drug applications ‘stable but more complex in 2012’

Despite austerity measures, EMA's annual report shows signs of biopharma resilience

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EMA recommends heart risk restriction for Servier’s Protelos

Use of osteoporosis drug likely to be further tightened up

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Sanofi’s four-strain flu vaccine Vaxigrip under review in EU

Pharma company also launches production of ingredient for malaria drug

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Clinical trials for EMA-submitted medicines move away from US and Europe

Most trial patients for drug marketing applications to EMA now come from rest of the world

ABPI publishes updated guidance on pharmacovigilance and digital media

In a guest blog, the ABPI's Esteban Herrero-Martinez explains what changes to European pharmacovigilance legislation mean for ABPI members

Agneta Brandt joins EMA as head of infrastructure

Joins as company prepares to move offices

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